Cereal-based Products Fortified With Legumes and Effects on Body Weight Management

NCT04176614 | Completed DMC

• 1 other identifier: 62/03072018
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Legumes are high nutritional quality foods and constitute a rich source of proteins and dietary fibers which have been associated with appetite regulation and body weight management. The purpose of the study is to investigate the effects of regular consumption of a cereal-based snack fortified with legumes on body weight reduction.

Conditions

Overweight and Obesity

Keywords

cereal-based snack fortified with legumes; body weight reduction

Outcome Measures

Primary Outcomes (1)

• Change in body weight

  Change in body weight after energy-restricted dietary intervention with cereal-legume snack compared to common cereal snack

  12 weeks

Study Arms (2)

cereal-legume snack

EXPERIMENTAL

Certain amount of cereal-legume snack daily for 12 weeks

Other: cereal-legume snack

cereal snack

ACTIVE COMPARATOR

Certain amount of cereal snack daily for 12 weeks

Other: cereal snack

Interventions

cereal-legume snack OTHER

cereal-legume biscuit

cereal-legume snack

cereal snack OTHER

cereal biscuit

cereal snack

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• normal exercise and dietary habits
• weight stable for at least 3 months before enrollment

You may not qualify if:

• diabetes
• pregnancy
• chronic medical illness
• use of nutritional supplements
• regular intense exercise
• alcohol consumption \> 2 drinks/day

Sponsors & Collaborators

• Harokopio University: lead
• National and Kapodistrian University of Athens: collaborator

Study Sites (1)

Laiko General Hospital, School of Medicine, National and Kapodistrian University of Athens

Athens, Attica, 11527, Greece

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Amalia Yanni, Dr

  Harokopio University

  PRINCIPAL INVESTIGATOR

• Alexander Kokkinos, Prof

  National and Kapodistrian University of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research and Teaching Associate-Staff, Principal Investigator

Model Details: Overweight/obese non diabetic subjects will follow an energy-restricted diet and supplemented with a cereal-based snack fortified with legumes (intervention group) or a common cereal snack (control group) for 12 weeks. Body weight, anthropometric, clinical and biochemical characteristics will be evaluated at the beginning and at the end of the study.

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: November 25, 2019
• Study Start: January 20, 2020
• Primary Completion: March 25, 2021
• Study Completion: March 25, 2021
• Last Updated: February 14, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)